T4 Zipper Toga — Class II medical device recall Z-1508-2018
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2018-05-02, distributed nationwide. Separation of material layers may occur, causing a potential risk of exposure to contaminants.
| Recall number | Z-1508-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, IE, JP, KR |
| Quantity | 34,570 products |
| Lot numbers | 17113139, 17113204 |
| Model numbers | 0400-830-000 |
Product
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Reason for recall
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1508-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.